Pain management, acute and chronic pain:
Injection:Surgery: Adjunct to general or regional anesthesia; preoperative medication; analgesic during anesthesia and in the immediate postoperative period.
Transdermal patch:Chronic pain: Management of pain in opioid-tolerant patients, severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Limitations of use: Reserve for use in patients for whom alternative treatment options (eg, nonopioid analgesics, immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Not indicated as an as-needed analgesic.
Transmucosal lozenge (eg, Actiq), buccal tablet (Fentora), intranasal (Lazanda), sublingual tablet (Abstral), sublingual spray (Subsys):Cancer pain, breakthrough: Management of breakthrough cancer pain in opioid-tolerant patients ≥18 years (Abstral, Fentora, Lazanda, Subsys) and ≥16 years (Actiq) of age who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain.
Limitations of use: Not for use in opioid non-tolerant patients. Not for use in the management of acute or postoperative pain, including headache/migraine, dental pain, or in the emergency department. As a part of the TIRF REMS Access program, these products may be dispensed only to outpatients enrolled in the program. For inpatient administration (eg, hospitals, hospices, and long-term care facilities that prescribe for inpatient use), patient and prescriber enrollment is not required.
Note: "Opioid-tolerant" patients are defined as patients who are taking at least:
Oral morphine 60 mg/day, or
Transdermal fentanyl 25 mcg/hour, or
Oral oxycodone 30 mg/day, or
Oral hydromorphone 8 mg/day, or
Oral oxymorphone 25 mg/day, or
Oral hydrocodone 60 mg/day, or
Equianalgesic dose of another opioid for at least 1 week